The basics of clinical trials
10 October 2014
What is a clinical trial?
A clinical trial is a research study, relying upon human volunteers, that allows scien7sts to inves7gate and answer specific medical ques7ons
Yesterday’s research leads to today’s treatments and
tomorrow’s cures.
What do trials accomplish?
Trials test new ways to…
¢ Prevent breast cancer ¢ Diagnose breast cancer ¢ Treat or cure breast cancer ¢ Improve quality of life during and aAer treatment
What do clinical trial “phases” mean?
• Ensuring safety • IdenEfying side effects • Confirming dosage
Each clinical trial is classified into one of 4 phases, depending on what it is tesEng:
• Further evaluaEng safety • TesEng effecEveness of a treatment
• Confirming effecEveness • Comparing to current standard treatments • Monitoring side effects
• Monitoring long term effects • IdenEfying new uses of the treatment
Phase 1
Phase 2
Phase 3
Phase 4
The doctor (Principal Inves7gator, or PI) in charge of the trial is responsible for a trial protocol which includes: ¢ Why the trial is required ¢ Who is eligible to par7cipate ¢ How many pa7ents are needed ¢ What drugs, if any, will be given;
how much and when ¢ What tests will be done,
and when ¢ What pa7ent informa7on will
be collected
How is a trial defined?
¢ Poten7ally eligible pa7ents are iden7fied ¢ They receive detailed informa7on from their doctors about the trial ¢ They are asked to sign an “Informed Consent” form to show that they have been properly informed about the study
What happens next?
How are paEents recruited?
¢ Pa7ents are chosen based on factors including age, gender, type and stage of breast cancer, treatment history and other medical condi7ons
¢ Some7mes pa7ents must be recruited from many countries in order to ensure that enough people will par7cipate so that the study will have sta7s7cal validity
¢ All Phase 3 trials (and some in Phase 2) use randomiza7on by computer to put pa7ents into groups receiving different treatments
¢ One group (the control group) receives the current standard of care ¢ One or more groups receive the therapy being tested, some7mes in different combina7ons
Do all paEents receive the same treatment?
How long does a trial last?
¢ Researchers monitor pa7ents for weeks, months or years, depending on the trial protocol
¢ Some trials follow pa7ents for more than 10 years, for example to track long-‐term pa7ent safety
The typical life of a trial
Recruitment
Study
Follow-‐up
Review
Protocol
Final Results
6 months – 10 years
6 months – 10 years
6 months – 5 years
EnEre duraEon of trial
Interim Results
What are the risks and benefits of parEcipaEng in a trial?
Benefits include: ¢ Access to promising new treatments not available outside the trial
¢ More individualized medical aXen7on, such as addi7onal tests and check-‐ups
¢ Contribu7on to improved treatments for future pa7ents
Risks include:
¢ Experimental treatment could prove ineffec7ve
¢ Treatment side effects ¢ Addi7onal 7me required at the hospital for tests and check-‐ups
Why support clinical trials?
¢ Clinical trials provide us with the knowledge we need to treat breast cancer beXer
¢ Now is the 7me for scien7sts to make significant progress in answering ques7ons about how to treat and cure breast cancer
Support trials and enable progress towards a cure for breast cancer
Today’s donaEons support tomorrow’s trials and
future cures.
Sources
For more informaEon: www.bigagainstbreastcancer.org www.breastcancertrials.org www.breastcancer.org/treatment/clinical_trials www.cancer.gov/clinicaltrials www.cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/ www.cancerresearchuk.org/about-‐cancer/trials/ www.clinicaltrials.gov